Package leaflet: Information for the user

Alendroarrow Veckotablett 70mg tablets

alendronic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do notpass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, See section 4.

What is in this leaflet

1. What Alendroarrow Veckotablettis and what it is used for

2. What you need to know before you take AlendroarrowVeckotablett

3. How to take AlendroarrowVeckotablett

4. Possible side effects

5. How to store AlendroarrowVeckotablett

6. Contents of the pack and other information

1. What AlendroarrowVeckotablett is and what it is used for

Alendronic acid belongs to a group of non-hormonal medicines known as bisphosphonates, which prevent bone loss from the body.

Alendronic acid is used to treat a condition called osteoporosis (brittle bones). This condition is common in women after the menopause. The earlier a woman reaches the menopause, the greater the risk of her developing osteoporosis.

Without treatment, osteoporosis can cause thinning and weakening of the bones in the skeleton which can then lead to fractures, usually of the hip, backbone and wrists. Fractures can occur easily in people suffering from osteoporosis including during normal everyday activities such as heavy lifting or from a minor injury or fall.

Alendronic acid helps to prevent bone loss and to build up bone which may have been lost due to osteoporosis. It can therefore reduce the risk of back and hip fractures.

2. What you need to know before you take AlendroarrowVeckotablett

Do not take AlendroarrowVeckotablett:

- If you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6).

- If you have certain disorders of the oesophagus (this is also called the gullet and is the tube that connects your mouth with your stomach) such as narrowing of the gullet or difficulty swallowing.

- If your doctor has told you that you have low calcium levels in your blood

- If you are unable to stand or sit upright for at least 30 minutes at a time.

Warnings and precautions

Talk to your doctor or pharmacist before taking AlendroarrowVeckotablett:

- If you have difficulty or pain when swallowing

- If you have inflammation of the stomach lining or the duodenum (first section of the small intestine)

- If you have a stomach ulcer or other digestive problems including bleeding in the stomach

- If you have had surgery on your stomach or gullet in the last year (not including pyloroplasty which is where the outlet from the stomach is widened)

- If your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus)

- If you have or have ever had any kidney problems

- If you have or have ever had low vitamin D levels. If so your doctor may wish to monitor your vitamin D levels during treatment with alendronic acid

- If you have or have had a condition called hypoparathyroidism (a condition where your parathyroid gland does not work properly)

- If you have or have had pain, swelling or numbness of the jaw, loosening of a tooth or a ‘heavy jaw feeling’

- If you are undergoing dental treatment or you are to undergo dental surgery

- If you have cancer, are undergoing chemotherapy or radiotherapy, are taking steroids, do not receive regular dental care, have a mouth infection or smoke. If so your doctor may want you to have a dental examination before starting treatment.

It is important to maintain good oral hygiene when being treated with AlendroarrowVeckotablett. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.

Children and adolescents

Alendroarrow Veckotablett should not be given to children and adolescents.

Other medicines and Alendroarrow Veckotablett

Do not take any other medicines orally (by mouth) at the same time as taking AlendroarrowVeckotablett. You should leave at least 30 minutes between your dose of Alendroarrow Veckotablettand any other oral medicines. It is important that you follow all of the advice given in section 3 (‘How to take Alendroarrow Veckotablett’).

You should speak to your Doctor before you take AlendroarrowVeckotablett if you are currently taking a non-steroidal anti-inflammatory drug (NSAID).

Tellyour doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Alendroarrow Veckotablett with food and drink

These tablets must be taken on an empty stomach as food and drink can greatly reduce the effectiveness of the medicine. You must take the tablets with a full glass of plain water at least 30 minutesbefore any other food or drink. It is important that you follow all of the advice given in section 3 (‘How to take Alendroarrow Veckotablett’).

Pregnancy and breast-feeding

Do not take AlendroarrowVeckotablett if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Driving and using machines

Alendroarrow Veckotablett is not expected to have any effects on your ability to drive and use machines. However in rare cases patients taking Alendroarrow Veckotablett can suffer from side effects including dizziness, severe muscle joint and bone pain and eye pain or inflammation. If you are affected in this way, you should contact your doctor before driving or using machinery.

AlendroarrowVeckotablett contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take AlendroarrowVeckotablett

Always take this medicine exactly as your doctor or pharmacisthas told you. Check with your doctor or pharmacist if you are not sure.

AlendroarrowVeckotablett must be taken once a week.

The following instructions are particularly important to ensure that your medicine is effective and to reduce the likelihood of the medicine irritating your oesophagus (gullet):

- Choose the day of the week that best suits you to take your tablet.

- Take one AlendroarrowVeckotablett each week on your chosen day.

- Immediately after getting up on your chosen day, take the Alendroarrow Veckotablett on an empty stomach. It should only be taken with a full glass of plain water (not less than 200ml) and should be taken at least 30 minutesbefore any other food, drink or medicine. Do not take your tablet with tea, coffee, mineral water or juice.

- The tablet must be swallowed whole. You must not chew or crush the tablet or allow it to dissolve in your mouth.

- Wait at least 30 minutes after taking the tablet before you drink or eat the first meal of the day or take any other medicine (this includes calcium supplements, vitamins and antacids (which are used to treat indigestion).

- Do not lie down after taking AlendroarrowVeckotablett. You must stay upright (sitting, standing or walking) for at least 30 minutes after you have swallowed the tablet. It is also important that you do not lie down before you have eaten the first meal of the day.

- Do not take your tablet at bedtime or before you get out of bed in the morning.

- If you find it difficult and/or painful to swallow, or you feel pain behind the breast-bone or new or worsened heartburn, stop taking the tablets and contact your doctor.

Your doctor may also ask you to take vitamin D or calcium supplements whilst you are taking AlendroarrowVeckotablett. If so, you should follow your doctor’s advice carefully.

It is important that you continue to take Alendroarrow Veckotablett for as long as your doctor recommends. Alendroarrow Veckotablett can only treat your osteoporosis effectively if you continue to take the tablets.

If you take more AlendroarrowVeckotablett than you should

If you take more AlendroarrowVeckotablett than you should, you may suffer from a stomach upset, heartburn, inflammation of the gullet or stomach, muscle and stomach cramps, spasms, weakness and fits. You shoulddrink a full glass of milk and contact your nearest doctor or hospital casualty department immediately. Do not try and make yourself sick (vomit) and do not lie down.

If you forget to take AlendroarrowVeckotablett

Take one tablet on getting up the next morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week on the day that you originally decided upon.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. You should stop taking Alendroarrow Veckotablett and tell your doctor immediately if you get any of the following symptoms:

Rare (may affect up to 1 in 1,000 people):

- sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body). This is known as ‘angioedema’.

- a rash, blistering or other effects on the skin, eyes, mouth or genitals, itching or high temperature (symptoms of severe skin reactions called Stevens-Johnson syndrome or toxic epidermal necrolysis).

If you have difficulty and/or pain when swallowing, you feel pain behind the breast-bone or new or worsened heartburn, stop taking Alendroarrow Veckotablett and contact your doctor.If you ignore these symptoms and continue to take your tablets it is likely that these gullet reactions may get worse.

The following side effects have been reported:

Very common (may affect more than 1 in 10 people):

- Muscle, joint or bone pain, which is sometimes severe

Common (may affect up to 1 in 10 people):

- Stomach pain, wind, indigestion, full or bloated feeling in the stomach, constipation, diarrhoea, regurgitation of acid from the stomach (reflux)

- Vertigo, dizziness

- Ulceration of the oesophagus (gullet), pain or difficulty when swallowing

- Headache

- Hair loss

- Itching (pruritus)

- Joint swelling, excess fluid (swelling), usually in the legs (peripheral oedema)

- Weakness or lack of energy

Uncommon (may affect up to 1 in 100 people):

- Feeling and being sick (nausea and vomiting), inflammation of the stomach, inflammation and/or thinning (erosion) of the gullet, black tarry stools

- Rash, reddening of the skin

- Changes in your sense of taste

- Inflammation of the eye

- Temporary flu-like symptoms (muscle pain, general feeling of illness and, in rare cases, fever) usually at the start of treatment.

Rare (may affect up to 1 in 1,000 people):

- Narrowing of the gullet

- Stomach or other peptic ulcers (although it is not clear whether these ulcers are caused by alendronic acid)

- Mouth and/or throat ulcers

- Skin rash with sensitivity to light

- Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

- Low calcium levels which may cause muscle cramps or spasms and tingling sensation in the fingers or around the mouth.

- Pain and/or inflammation of the jaw (this is more common in people who have had a tooth taken out and/or a mouth infection)

Very rare (may affect up to 1 in 10,000 people)

- Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alendroarrow Veckotablett

Keep this medicine out of the sight and reach of children.

Do not use this medicineafter the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What AlendroarrowVeckotablett contains:

- The active substance is alendronic acid. Each tablet contains 70mg of alendronic acid as sodium alendronate trihydrate.

- The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate.

What Alendroarrow Veckotablett look like and contents of the pack

AlendroarrowVeckotablett are white to off-white oval tablets stamped ’AN 70‘ on one side and ‘>’ on the other.

The tablets are available in blister packs of 2, 4, 8, 12 and 40 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<[To be completed nationally]>

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

Manufacturers

Arrow Pharm (Malta) Limited, HF 62, Hal Far Industrial Estate, Hal Far, BBG 3000, Malta

Qualiti (Burnley) Limited, Talbot Street, Briercliffe, Burnley, BB10 2JY, United Kingdom

Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany

Chester Medical Solutions, Apex Court, Bassendale Road, Bromborough, Wirral, CH62 3RE, United Kingdom

Medicofarma S.A., ul. Żelazna 58, 00-866 Warszawa, Poland

Actavis Ltd,, BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

Malta Alendronic Acid 70mg Tablets

Poland Alendronate Arrow 70mg

Sweden Alendroarrow Veckotablett 70 mg tabletter

Hungary Fortimax tabletta

This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.

<[To be completed nationally]>

2016-04-14